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YY 0096-2019

Chinese Standard: 'YY 0096-2019'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY 0096-2019English289 Add to Cart Days<=3 Co-60 teletherapy unit Valid YY 0096-2019
YY 0096-2019Chinese15 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YY 0096-2019 (YY0096-2019)
Description (Translated English) Co-60 teletherapy unit
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C43
Classification of International Standard 11.040.60
Word Count Estimation 14,161
Date of Issue 2019-05-31
Date of Implementation 2020-12-01
Drafting Organization Beijing Medical Device Inspection Institute, Shandong Xinhua Medical Equipment Co., Ltd., China Nuclear Power Research and Design Institute Equipment Manufacturing Plant
Administrative Organization Technical Committee of Radiotherapy, Nuclear Medicine and Radiation Dosimetry Equipment of the National Medical Electrical Equipment Standardization Technical Committee (SAC/TC 10/SC 3)
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY 0096-2019
Co-60 teletherapy unit
ICS 11.040.60
C43
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0096-2009
Cobalt-60 teletherapy machine
Published on.2019-05-31
2020-12-01 implementation
State Drug Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 1
4.1 Environmental conditions 1
4.2 Performance 2
4.3 Electrical Safety 3
5 Test method 3
5.1 Test conditions 3
5.2 Performance 3
5.3 Electrical Safety 7
Appendix A (Normative Appendix) Method of Measuring Absorbed Dose Rate 8
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0096-2009 "Cobalt-60 Teletherapy Machine".
Compared with YY 0096-2009, the main technical changes except the editorial modification are as follows.
--- Removed the introduction (see the introduction of the.2009 edition);
--- Normative references have added GB/T 17857 and YY 0505 (see 2);
--- Revised some terms and definitions (see 3, 3 of the.2009 edition);
--- Removed "type and basic parameters" (see 4 of the.2009 edition);
--- Increased performance requirements for the treatment bed (see 4.2.10);
--- Increased the requirement for absorbed dose rate (see 4.2.11);
--- Revised the test method for the error of the isocenter position (see 5.2.1, 6.5 of the.2009 edition);
--- Revised the test method for the trimmed penumbra width (see 5.2.2, 6.6 of the.2009 edition);
--- Revised the test method for the deviation between the field and the radiation field boundary (see 5.2.5, 6.9 of the.2009 edition);
--- Revised the test method for the display of the radiation field (see 5.2.8, 6.12 of the.2009 edition);
--- Revised electrical safety requirements and test methods (see 4.3, 5.3,.2009 editions 5.14, 6.15);
--- Removed "noise" (see 5.11 of the.2009 edition);
--- Removed the "look" (see 5.12 of the.2009 edition);
--- Removed the "ruler scale" (see 5.13 of the.2009 edition);
--- Removed the "radiation head movement" [see.2009 edition of 5.7a)];
--- Removed the "inspection rules" (see 7 of the.2009 edition);
--- Removed "flag, packaging, transportation, storage" (see 8 of.2009 edition);
--- Removed the appendix "Test methods for isocenter locations" (see Appendix A of the.2009 edition);
--- Added "Measurement method for absorbed dose rate" (see Appendix A).
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is divided into the Technical Committee of Radiotherapy, Nuclear Medicine and Radiation Dosimetry Equipment of the National Medical Electrical Equipment Standardization Technical Committee.
(SAC/TC10/SC3) is under the jurisdiction.
This standard was drafted. Beijing Medical Device Inspection Institute, Shandong Xinhua Medical Instrument Co., Ltd., China Nuclear Power Research and Design
Hospital equipment manufacturing plant.
The main drafters of this standard. Jiao Chunying, Cheng Xige, Ma Binren, Huang Jifa, Xu Xiang, Yu Bin.
The previous versions of the standards replaced by this standard are.
---YY 0096-1992, YY 0096-2009.
Cobalt-60 teletherapy machine
1 Scope
This standard specifies the requirements and test methods for the Cobalt-60 remote treatment machine.
This standard applies to the cobalt-60 remote treatment machine (hereinafter referred to as the treatment machine), which is mainly used for medical treatment for radiation therapy.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety
GB 9706.17 Medical electrical equipment - Part 2. Particular requirements for safety of gamma beam therapy equipment
GB/T 17857 Medical radiology terms (radiation therapy, nuclear medicine and radiation dosimetry equipment)
YY 0505 Medical electrical equipment - Part 1-2. Safety general requirements. Parallel standard. Electromagnetic compatibility requirements and testing
3 Terms and definitions
The following terms and definitions as defined in GB 9706.1, GB 9706.17 and GB/T 17857 apply to this document.
3.1
Radiation head radiationhead
A mechanism that stores functions such as storing a radiation source and emitting a radiation beam.
3.2
Penumbra penumbra
Since the source is a non-point source, there is a certain volume, and the scattering of the rays in the radiation field and the thickness of the useful rays passing through the collimator are inconsistent,
Make a certain gradient from large to small in the vicinity of the determined radiation field edge, 80% absorbed dose at the radiation beam axis in the radiation range
Point and the area covered by the 20% absorbed dose point.
3.3
(gamma beam) teletherapy (gammabeam) teletherapy
The distance (SSD) between the radiation source and the skin is not less than the gamma ray beam emitted by the radionuclide placed in the radiation source assembly.
External beam medical treatment performed at 50 cm.
4 requirements
4.1 Environmental conditions
Unless otherwise stated in the documentation, the following conditions should be met.
a) Ambient temperature range. 10 ° C ~ 40 ° C;
b) Relative humidity range. 30%~75%;
c) Atmospheric pressure range. 70kPa~106kPa.
YY 0096-2019
Co-60 teletherapy unit
ICS 11.040.60
C43
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0096-2009
Cobalt-60 teletherapy machine
Published on.2019-05-31
2020-12-01 implementation
State Drug Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 1
4.1 Environmental conditions 1
4.2 Performance 2
4.3 Electrical Safety 3
5 Test method 3
5.1 Test conditions 3
5.2 Performance 3
5.3 Electrical Safety 7
Appendix A (Normative Appendix) Method of Measuring Absorbed Dose Rate 8
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0096-2009 "Cobalt-60 Teletherapy Machine".
Compared with YY 0096-2009, the main technical changes except the editorial modification are as follows.
--- Removed the introduction (see the introduction of the.2009 edition);
--- Normative references have added GB/T 17857 and YY 0505 (see 2);
--- Revised some terms and definitions (see 3, 3 of the.2009 edition);
--- Removed "type and basic parameters" (see 4 of the.2009 edition);
--- Increased performance requirements for the treatment bed (see 4.2.10);
--- Increased the requirement for absorbed dose rate (see 4.2.11);
--- Revised the test method for the error of the isocenter position (see 5.2.1, 6.5 of the.2009 edition);
--- Revised the test method for the trimmed penumbra width (see 5.2.2, 6.6 of the.2009 edition);
--- Revised the test method for the deviation between the field and the radiation field boundary (see 5.2.5, 6.9 of the.2009 edition);
--- Revised the test method for the display of the radiation field (see 5.2.8, 6.12 of the.2009 edition);
--- Revised electrical safety requirements and test methods (see 4.3, 5.3,.2009 editions 5.14, 6.15);
--- Removed "noise" (see 5.11 of the.2009 edition);
--- Removed the "look" (see 5.12 of the.2009 edition);
--- Removed the "ruler scale" (see 5.13 of the.2009 edition);
--- Removed the "radiation head movement" [see.2009 edition of 5.7a)];
--- Removed the "inspection rules" (see 7 of the.2009 edition);
--- Removed "flag, packaging, transportation, storage" (see 8 of.2009 edition);
--- Removed the appendix "Test methods for isocenter locations" (see Appendix A of the.2009 edition);
--- Added "Measurement method for absorbed dose rate" (see Appendix A).
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is divided into the Technical Committee of Radiotherapy, Nuclear Medicine and Radiation Dosimetry Equipment of the National Medical Electrical Equipment Standardization Technical Committee.
(SAC/TC10/SC3) is under the jurisdiction.
This standard was drafted. Beijing Medical Device Inspection Institute, Shandong Xinhua Medical Instrument Co., Ltd., China Nuclear Power Research and Design
Hospital equipment manufacturing plant.
The main drafters of this standard. Jiao Chunying, Cheng Xige, Ma Binren, Huang Jifa, Xu Xiang, Yu Bin.
The previous versions of the standards replaced by this standard are.
---YY 0096-1992, YY 0096-2009.
Cobalt-60 teletherapy machine
1 Scope
This standard specifies the requirements and test methods for the Cobalt-60 remote treatment machine.
This standard applies to the cobalt-60 remote treatment machine (hereinafter referred to as the treatment machine), which is mainly used for medical treatment for radiation therapy.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety
GB 9706.17 Medical electrical equipment - Part 2. Particular requirements for safety of gamma beam therapy equipment
GB/T 17857 Medical radiology terms (radiation therapy, nuclear medicine and radiation dosimetry equipment)
YY 0505 Medical electrical equipment - Part 1-2. Safety general requirements. Parallel standard. Electromagnetic compatibility requirements and testing
3 Terms and definitions
The following terms and definitions as defined in GB 9706.1, GB 9706.17 and GB/T 17857 apply to this document.
3.1
Radiation head radiationhead
A mechanism that stores functions such as storing a radiation source and emitting a radiation beam.
3.2
Penumbra penumbra
Since the source is a non-point source, there is a certain volume, and the scattering of the rays in the radiation field and the thickness of the useful rays passing through the collimator are inconsistent,
Make a certain gradient from large to small in the vicinity of the determined radiation field edge, 80% absorbed dose at the radiation beam axis in the radiation range
Point and the area covered by the 20% absorbed dose point.
3.3
(gamma beam) teletherapy (gammabeam) teletherapy
The distance (SSD) between the radiation source and the skin is not less than the gamma ray beam emitted by the radionuclide placed in the radiation source assembly.
External beam medical treatment performed at 50 cm.
4 requirements
4.1 Environmental conditions
Unless otherwise stated in the documentation, the following conditions should be met.
a) Ambient temperature range. 10 ° C ~ 40 ° C;
b) Relative humidity range. 30%~75%;
c) Atmospheric pressure range. 70kPa~106kPa.
Related standard:   YY/T 0093-2013  YY/T 0094-2013
Related PDF sample:   YY/T 0106-2008  YY/T 0794-2010
   
 
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